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Health Canada-Initiated Recalls

Section 21.3 orders​

Under Section 21.3 of the Food and Drugs Act, Health Canada may order a person to recall a medical device if:

  • The Minister believes the device presents a serious risk of injury to health
  • The person has failed to voluntarily recall the device

A Section 21.3 order is a legally binding direction — non-compliance can result in prosecution.

When Health Canada acts​

Health Canada follows a risk-based approach and typically seeks voluntary compliance first before issuing mandatory orders. However, if an immediate serious health risk is identified, Health Canada may proceed directly to a Section 21.3 order without first requesting voluntary recall. This collaborative approach encourages manufacturers to act proactively, but does not prevent Health Canada from issuing an order immediately if public health is at serious risk. Situations that may lead to Health Canada-initiated action:

  • A manufacturer refuses to recall despite evidence of a significant safety deficiency
  • A recall is initiated but not executed effectively (low response rate)
  • A company is unresponsive to Health Canada enquiries about a safety issue
  • Imported devices are seized at the border before the importer initiates a recall

Seizure authority​

Health Canada inspectors have authority to seize medical devices suspected to be non-compliant or unsafe under the Food and Drugs Act.

Public advisories​

Health Canada may issue a public advisory independently of (or in addition to) the manufacturer's Field Safety Notice when:

  • There is an urgent public health risk
  • The affected patient population is broad
  • The manufacturer's communications are considered insufficient

Public advisories are posted on Health Canada's Recalls and Safety Alerts database and distributed through the Canadian Adverse Event Reporting Program (CAARP).

Legislative source: Food and Drugs Act, RSC 1985, c F-27, s 21.3 (orders to recall); s 23 (seizure and detention)